MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-04-06 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..
[41961130]
The customer contacted a siemens customer care center (ccc) specialist. The discordant results were obtained when the operator switched the water and probe wash lines. The customer switched the lines back to their respective positions. The ccc specialist instructed the customer to run decontamination twice before repeating quality controls. The customer then primed the syringes and water pump by performing a decontamination diagnostic procedure. The customer ran quality controls and patient samples, which were acceptable. The cause of the discordant results on patient samples was due to the user error. This instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[41961131]
Discordant results were obtained on multiple patient samples on an immulite instrument. The discordant results were not reported to the physician(s). All the discordant results were less than assay limits. After troubleshooting, the customer repeated the samples and the results were acceptable. It is unknown if the repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2016-00022 |
| MDR Report Key | 5550089 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-04-06 |
| Date of Report | 2016-03-15 |
| Date of Event | 2016-03-15 |
| Date Mfgr Received | 2016-03-15 |
| Date Added to Maude | 2016-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE |
| Generic Name | IMMULITE |
| Product Code | JJQ |
| Date Received | 2016-04-06 |
| Model Number | IMMULITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-06 |